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Comparison of effectiveness of group behavioral activation intervention and Mindfulness-Based Cancer Recovery intervention based on online method on sleep quality, pain perception, anxiety and depression of breast cancer patients

Protocol summary

Study aim
Comparison of the effectiveness of active behavioral group intervention with mindfulness on improving cancer by online method on sleep quality, pain perception, disease, complications of breast cancer
Design
A controlled, parallel-group, unblinded, randomized, phase 2 clinical trial on 102 patients. The site https://www.sealedenvelope.com is used for randomization by permutation block method with the explanation that; Each block has 6 members.
Settings and conduct
Omid Hospital, online in virtual space Before the start of any intervention program, an explanatory meeting will be held for people with entry conditions and explanations will be given about the intervention, and written consent will be completed by the participants. Then we ask all patients to complete the Beck Depression and Anxiety Questionnaire, the Brief Pain Intensity Questionnaire (BPI) and the Petersburg Sleep Quality Questionnaire (PSQI). Patients who completed all questionnaires will be randomly assigned to 3 groups: control group, online MBCR group (N=30) and online group behavioral activation group (N=30)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Their age group should be between 20 and 65 years old. Definite diagnosis of breast cancer. Exclusion criteria: Non-cooperation in the treatment process. Diagnosis of psychiatric disorders.
Intervention groups
Control group: no online intervention based on mindfulness and online intervention of behavioral activation will be implemented on the control members. Online MBCR Group: Mindfulness-Based Cancer Recovery (MBCR) is an 8-week group training program based on scientifically tested and internationally recognized evidence for cancer patients. Online Group Behavioral Activation Group: Activation Behavioral Therapy
Main outcome variables
Sleep quality, pain intensity, anxiety, depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230529058323N1
Registration date: 2023-08-30, 1402/06/08
Registration timing: registered_while_recruiting

Last update: 2023-08-30, 1402/06/08
Update count: 0
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
Hasan Shabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 6082
Email address
shabanih5@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of group behavioral activation intervention and Mindfulness-Based Cancer Recovery intervention based on online method on sleep quality, pain perception, anxiety and depression of breast cancer patients
Public title
Comparison of effectiveness of group behavioral activation intervention and Mindfulness-Based Cancer Recovery intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Their age group is between 20 and 65 years. Definitive diagnosis of breast cancer by an oncologist. Have minimum education to answer the questionnaires. person in the early stages of receiving treatment (early breast cancer without metastasis) smartphone access to the internet
Exclusion criteria:
Absence of more than two sessions. Unwillingness of the person to complete the interventions Having previous experience of yoga or meditation exercises in the past few months Under treatment by a psychologist or other psychiatrist Failure to respond to questionnaires Failure to carry out relevant instructions and exercises in meetings
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization: Block randomization is performed by first creating blocks of desired size from the target data. These blocks are then randomly shuffled and finally arranged in order, resulting in a randomly block-permuted sequence. Tool Used: The website https://www.sealedenvelope.com was used with the explanation that each block consists of 6 members and the shape of the blocks can be, for example: [ABCABC], [BBAACC], [BCACBA], etc. The codes A, B, and C are randomly assigned to intervention and control groups. The website selects 18 random blocks out of all possible six-member blocks to ensure that all patients are included in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Omid Hospital, alaNadasht Crossroads, Koh Sengi St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Approval date
2023-01-31, 1401/11/11
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.055

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Depression
Timepoint
1-before the intervention (week zero) 2-after the intervention (60 days after the evaluation) (initial, 8th week) 3- 30 days after the end of the intervention (12th week)
Method of measurement
Beck's depression questionnaire

2

Description
Pain
Timepoint
1-before the intervention (week zero) 2-after the intervention (60 days after the evaluation) (initial, 8th week) 3- 30 days after the end of the intervention (12th week)
Method of measurement
Pain Intensity Scale Questionnaire (BPI)

3

Description
Anxiety
Timepoint
1-before the intervention (week zero) 2-after the intervention (60 days after the evaluation) (initial, 8th week) 3- 30 days after the end of the intervention (12th week)
Method of measurement
Beck's anxiety questionnaire

Secondary outcomes

1

Description
Sleep quality
Timepoint
1-before the intervention (week zero) 2-after the intervention (60 days after the evaluation) (initial, 8th week) 3- 30 days after the end of the intervention (12th week)
Method of measurement
Pittsburgh Sleep Quality Index

Intervention groups

1

Description
The first intervention group: MBCR intervention group: Mindfulness-based cancer recovery (MBCR) is an 8-week training program and a group based on tested and internationally recognized scientific evidence for cancer patients. The program was developed by Dr. Linda Carlson and Dr. Michael Speck at the University of Calgary and has been running as a clinical program for over 20 years.
Category
Treatment - Other

2

Description
The second intervention group: group behavioral activation: the members of the online behavioral activation intervention group will also receive behavioral activation training for 8 sessions of 50 minutes According to from Leahy, Holland & McGinn protocol of Behavioral activation therapy.
Category
Treatment - Other

3

Description
Members of the control group: No online intervention based on mindfulness and online intervention of behavioral activation will be implemented on the control members and they will only receive routine care. The meaning of routine care is the medical treatment required based on the opinion of the attending physician.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Farshad Sheybani
Street address
Omid Hospital, Alandasht Crossroad, Kohsang, Khorasan Razavi, st, Mashhad, ad,i St,
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6083
Fax
+98 51 3842 8622
Email
sheibanifr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Khalil Abnous
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3538 1049
Fax
+98 51 3843 0249
Email
abnouskh@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hore-ameli St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Email
sheibanifr@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hore-Ameli St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919598313
Phone
+98 51 3711 2701
Email
sheibanifr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hore-Ameli St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
0098513711270
Email
sheibanifr@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The SPSS file contains the information of the questionnaires. The scores of people in the questionnaires can be shared after removing the names of the participants.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Send an email to the responsible author to receive the SPSS results file
From where data/document is obtainable
Responsible Author: Dr Farshad Sheybani Email: sheibanifr@mums.ac.ir
What processes are involved for a request to access data/document
The applicant can email the responsible author and receive the result file within 10 days.
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